The MHRA has reclassified Cialis Together (tadalafil), used for erectile dysfunction, so that it can now be made available for purchase over-the-counter without a prescription.
Erectile dysfunction becomes more common with increasing age, and is "seen in 50 - 55% of men between 40 and 70 years old", according to the British Association of Urological Surgeons.
Research had identified that in 2021, every 7.5 seconds, a medication for erectile dysfunction was prescribed to people in England and Wales. In that same year the NHS spent over £13 million on prescriptions for erectile dysfunction treatments.
Researchers also revealed that between 2009 and 2019, the rate of primary care prescriptions (measured as the number of items per 1000 men) had doubled. There were 2,145,393 items for erectile dysfunction prescribed in 2009 and 4,505,623 in 2019 – an increase of 110%, they said.
In 2003 Cialis was launched, and now 20 years later, as it celebrates its 'China anniversary', the Medicines and Healthcare products Regulatory Agency (MHRA) has announced that Cialis Together – which contains 10 mg tadalafil citrate – will, if marketed, be available to purchase from pharmacies.
The decision to make the product available from pharmacies without a prescription for adult men with erectile dysfunction was made following a "reassuring assessment" of the safety of the product and advice from the Commission on Human Medicines, explained an MHRA spokesperson.
Viagra (sildenafil) is also celebrating an anniversary this year – its silver anniversary – having been launched 25 years ago in 1998. It has been available to purchase in pharmacies as Viagra Connect (sildenafil 50-mg tablets) since 2018, when it was first reclassified with Pharmacy legal status.
Convenient, Legitimate, and Safe Care
The MHRA pointed out that "if marketed", Cialis Together would be sold from pharmacies following a discussion with the pharmacist. The regulator emphasised that pharmacists would determine whether treatment was appropriate for the patient, and would also provide advice on erectile dysfunction, usage of the medicine, potential side effects, and if further consultation with a general practitioner was required. An MHRA spokesperson reassured men that pharmacists would have access to training materials and a checklist that would enable them to advise men on whether the product was appropriate and safe for them to use.
Dr Laura Squire, MHRA's chief officer for healthcare, quality and access expressed that the announcement came as "good news" for men as it would enable men with erectile dysfunction to obtain treatment "conveniently", and "safely". She added that this move would give men "greater control over their choices", and would swell awareness of erectile dysfunction.
"Erectile dysfunction medicines are a popular target for criminals selling unlicensed and counterfeit medicines," alerted the MHRA.
Dr Squire emphasised how important it was that men had "access to quality and legitimate care".
The MHRA said that Cialis Together will be available through pharmacies without a prescription with a maximum dose of one tablet each day, and a maximum pack size of eight tablets. The product will not be sold to those with severe cardiovascular disorders; at high cardiovascular risk; severe kidney or severe liver failure; or taking certain interacting medicines, explained the MHRA, and added that use of Cialis Together in these groups of men must "continue to be under the supervision of a doctor".